Comprehensive Evaluation of Ischemic Heart Disease Using MRI
Recruitment status was Recruiting
The aim is to develop a comprehensive cardiac Magnetic Resonance Imaging (MRI) protocol combining an Ultrafast perfusion technique, high resolution rapid cine and viability imaging together with whole heart coronary Magnetic Resonance Angiography (MRA). This new protocol will be tested in a group of volunteers and compared in patients using coronary angiography as the gold standard. It is expected that this improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary artery disease and may obviate the need for other more expensive and invasive diagnostic tests currently used.
Heart Disease, Ischemic
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Comprehensive Evaluation of Ischemic Heart Disease Using MRI|
- Compare sensitivity and specificity in detection of significant coronary artery disease in patients that had been referred to the Catheterization Lab with suspected ischemic disease using the comprehensive cardiac Magnetic Resonance Imaging protocol [ Time Frame: 12 months ] [ Designated as safety issue: No ]The results from the MR images analysis will be compared to conventional coronary angiography. Sensitivity, specificity, accuracy and statistical analysis will be carried out for each of the MR techniques separately and then combining results from all of the techniques together.
- Number of participants with adverse events to demonstrate feasibility of a comprehensive cardiac Magnetic Resonance Imaging protocol [ Time Frame: 12 months ] [ Designated as safety issue: No ]Adverse events such as tolerability for drugs and scan time during a "one stop shop" coronary heart disease comprehensive cardiac MRI study.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
No Intervention: Adenosine
Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.
Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins
Other Name: (Adenoscan)
Coronary heart disease is the leading cause of death and disability in the US, accounting for about one-third of all deaths in subjects over age 35.
With the development of newer Magnetic Resonance Imaging (MRI) techniques, such as faster pulse sequences and parallel imaging, cardiac MRI has become a routine tool for the evaluation and detection of myocardial ischemic disease. First pass myocardial perfusion (FPMP) using MRI is increasingly being used to assess ischemic heart disease. MRI offers the advantages of spatial resolution sufficient to differentiate between subendocardial and subepicardial perfusion; shorter examination time and also lack of ionizing radiation. Left ventricle cine gradient echo imaging can be used to assess regional ventricular function. Left ventricular myocardial viability can also be easily assessed at the same time in order to determine the amount of viable left ventricular myocardium and the percentage of irreversibly scarred myocardium by delayed enhanced images. Viability imaging is usually added to the perfusion protocol to increase specificity by allowing detection of fixed perfusion defects, which represent scar. The ultimate cardiac MRI protocol would be to combine both of these imaging strategies with a reliable and accurate coronary Magnetic Resonance Angiography(MRA) technique, such that obstructive coronary artery disease could be evaluated comprehensively at the same time. If all of these techniques can be combined together in a single study, it may be feasible to finally achieve a "one stop shop" for cardiac MRI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234870
|Contact: James C Carr, MDemail@example.com|
|Contact: Aya Kino, MDfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern University||Enrolling by invitation|
|Chicago, Illinois, United States, 60611|
|Chicago, Illinois, United States, 60611|
|Contact: James C Carr, MD 312-695-4218|
|Contact: Aya Kino, MD 312-695-0890|
|Principal Investigator: James C Carr, MD|
|Principal Investigator:||James C Carr, MD||Northwestern University|